Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
a 48-week, Double Blind, Randomized, Multinational, Multicentre, "Fixed Combination" Beclomethasone Dipropionate Plus Formoterol Fumarate Versus Formoterol in Patients With Severe Chronic Obstructive Pulmonary Disease
| Verified date | October 2021 |
| Source | Chiesi Farmaceutici S.p.A. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease
| Status | Completed |
| Enrollment | 1199 |
| Est. completion date | July 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | Inclusion Criteria: - Severe COPD - At least one COPd exacerbation in previous year Exclusion Criteria: - Asthma, allergic rhinitis or other atopic disease - Unstable concurrent disease: - Evidence of heart failure |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | UCL Medical School | London |
| Lead Sponsor | Collaborator |
|---|---|
| Chiesi Farmaceutici S.p.A. |
United Kingdom,
Siddiqui SH, Pavord ID, Barnes NC, Guasconi A, Lettis S, Pascoe S, Petruzzelli S. Blood eosinophils: a biomarker of COPD exacerbation reduction with inhaled corticosteroids. Int J Chron Obstruct Pulmon Dis. 2018 Nov 6;13:3669-3676. doi: 10.2147/COPD.S179425. eCollection 2018. — View Citation
Singh D, Kampschulte J, Wedzicha JA, Jones PW, Cohuet G, Corradi M, Higenbottam T, Petruzzelli S, Vestbo J. A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations. Eur Respir J. 2013 Jan;41(1):12-7. doi: 10.1183/09031936.002 — View Citation
Singh D, Vezzoli S, Petruzzelli S, Papi A. The efficacy of extrafine beclomethasone dipropionate-formoterol fumarate in COPD patients who are not "frequent exacerbators": a post hoc analysis of the FORWARD study. Int J Chron Obstruct Pulmon Dis. 2017 Nov 3;12:3263-3271. doi: 10.2147/COPD.S141416. eCollection 2017. — View Citation
Wedzicha JA, Singh D, Vestbo J, Paggiaro PL, Jones PW, Bonnet-Gonod F, Cohuet G, Corradi M, Vezzoli S, Petruzzelli S, Agusti A; FORWARD Investigators. Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations. Respir Med. 2 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Exacerbation rate Change in pre-dose FEV1 | 0-4-12-24-36-48 weeks | ||
| Secondary | Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication | 0-4-12-24-36-48 weeks |
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